Dr. Von Eschenbach is back in the wood shed. This week, Reps Dingell and Stupak sent the FDA a letter (click here to read) demanding responses and more information, and alleging that the Agency might have been aware of GMP compliance issues involving some Ranbaxy products sold in the U.S., but that it failed to respond. Ranbaxy denies any and all allegations, so it will be interesting to see if, and what, evidence eventually surfaces.
The letter, tellingly, refers to and contrasts the Agency's perceived indifference today with its previous FDA response to the generic drug scandal of yesteryear....The representatives expect a response within two weeks.
Next week, MetricStream will be sponsoring what promises to be a very interesting webinar (summarized here) on FDA's Risk-Based Inspection Methods. A top person at Parexel Consulting, a company whose name had been mentioned in some news reports on Ranbaxy data allegations, will be speaking, which could lead to some interesting Q&A...
Although criticism of FDA may be justified, one almost senses a nostalgia on the part of regulators for the old fashioned "command and control" approach to pharmaceutical industry regulation. One hopes that regulators and the public can develop a greater understanding and appreciation for risk-based approaches. They're not playing "rock-paper-scissors" at FDA. (Or are they?)
